Wearable Sensors and Smartphone for Stroke

Overseen By Kathy Piela, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Botulinum toxin

Disqualifiers: Cognitive impairments, Severe aphasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 93

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if wearable sensor data visualization on smartphones can improve the use of the stroke-affected limb during everyday activities. Chronic stroke survivors (\>12 months from onset) ages 18-80 years old with residual upper extremity motor impairments may be eligible to participate. The main question it aims to answer is: Does the mobile health (mHealth) intervention help to improve the use of the stroke-affected upper-limb during daily living? The study is designed so each participant serves as their own control. Researchers will compare information from the baseline, intervention, and retention time periods to see if visualizing the data on the smartphone impacts the participant's daily use of the arm. Participants will be asked to wear a set of wearable ring and wrist sensors and interact with a custom-designed smartphone app, aiming to increase the use of their stroke-affected limb during daily activities as much as possible. They will receive feedback from the app, communicate with study therapists, participate in goal setting, complete clinical assessments, and share about their experience using the system during a virtual interview.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, significant changes in your medication plan during the study that might affect arm use are not allowed.

What data supports the effectiveness of the treatment mHealth using wearable sensors and smartphones for stroke?

Research shows that wearable sensors and smartphone technology can help monitor and assess stroke patients' movements, providing valuable information for personalized rehabilitation. This approach can be cost-effective and accessible, offering a promising alternative to traditional rehabilitation methods. ^{1 2 3 4 5}

Is it safe to use wearable sensors and smartphone apps for stroke monitoring and prevention?

Research shows that wearable devices and smartphone apps are generally safe for monitoring heart conditions like atrial fibrillation and managing stroke risk factors. They help in early detection and management of conditions, and patients find them useful and are open to using them alongside regular medical care. ^{4 6 7 8 9}

How does the mHealth treatment using wearable sensors and smartphones differ from other stroke treatments?

The mHealth treatment for stroke is unique because it uses wearable sensors and smartphones to monitor and assess patients both in clinical settings and at home, allowing for personalized rehabilitation. This approach provides real-time feedback and detailed evaluation of motor impairments, which can help tailor therapy to individual needs, unlike traditional methods that may not offer such continuous and comprehensive monitoring. ^{3 10 11 12 13}

Research Team

Paolo Bonato, PhD

Principal Investigator

Director of Motion Analysis Laboratory

Eligibility Criteria

This trial is for chronic stroke survivors aged 18-80 with upper limb motor impairments who are more than 12 months post-stroke onset. Participants should be able to use a smartphone and wear sensors on their affected limb.

Inclusion Criteria

I can fully extend my fingers, thumb, and wrist.

Participants must be able to read, write, and understand English at a level sufficient to comprehend study materials and provide informed consent.

I survived a stroke and it's been over a year since.

Exclusion Criteria

I have not used botulinum toxin for motor issues in the last 3 months.

Cognitive impairments that may affect the ability to understand and follow instructions (score < 24 in the Mini Mental State Examination)

Previous participation in constraint-induced movement therapy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Baseline

Participants wear wrist and index finger-worn sensors bilaterally for 14 days and self-annotate activities

2 weeks

Continuous monitoring with self-annotation every 90 minutes

Intervention

Participants interact with the Intervention app, receive feedback, and engage in Zoom calls with therapists

4 weeks

3 Zoom calls with research therapist

Retention

Participants continue wearing sensors without app feedback or clinician interactions to assess withdrawal effects

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the retention phase

4 weeks

Treatment Details

Interventions

• mHealth

Trial Overview The study tests if visual feedback from wearable sensors displayed on smartphones can increase the use of the stroke-affected arm in daily life. It's a self-controlled study where participants' activity levels before, during, and after using the app are compared.

Participant Groups

Group I: mHealth Intervention Experimental Treatment 1 Intervention

Members of this group will receive the wearable sensors and mHealth smartphone application.

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Findings from Research

Wearable technology can significantly enhance stroke rehabilitation by providing objective assessments and monitoring of patients' progress both in clinical settings and at home, which can lead to more personalized therapy plans.

The review highlights the current use of various wearable sensors focused on upper extremity rehabilitation, discussing both the challenges faced in implementation and the opportunities for developing reliable tools to improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable technology in stroke rehabilitation: towards improved diagnosis and treatment of upper-limb motor impairment. Maceira-Elvira, P., Popa, T., Schmid, AC., et al.[2020]

The Stroke Riskometer App was tested in a pilot study with 50 participants to assess its feasibility in improving stroke awareness and modifying risk behaviors, showing good retention at 87%.

While the App group showed a slight improvement in cardiovascular health compared to the control group, the results were not statistically significant, indicating the need for a larger trial to fully evaluate its effectiveness in primary stroke prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Technology for Primary Stroke Prevention: A Proof-of-Concept Pilot Randomized Controlled Trial. Krishnamurthi, R., Hale, L., Barker-Collo, S., et al.[2023]

Smartphone apps can significantly improve the management of risk factors like hypertension and diabetes in stroke patients, which is crucial for preventing recurrent strokes, based on a review of 10 studies.

Patients generally find these mobile health apps useful and are receptive to using them, as long as they complement traditional medical care rather than replace it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of smartphone apps in secondary stroke prevention]. Fruhwirth, V., Enzinger, C., Weiss, E., et al.[2020]

A qualitative study involving 17 physical therapists and 3 individuals with stroke identified key considerations for developing stroke-specific wearable monitoring technology, emphasizing the need for devices that accommodate the variability in patient needs and rehabilitation goals.

Stakeholders believe that such technology could significantly enhance rehabilitation practices, but it must include crucial design features and address barriers to adoption to be effectively integrated into clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke. Louie, DR., Bird, ML., Menon, C., et al.[2020]

The SQUID smart shirt, which uses electromyography (EMG) and heart rate monitoring, offers a promising low-cost solution for remote rehabilitation of stroke patients, allowing for home-based therapy with real-time feedback.

Initial testing with a healthy subject demonstrated the system's ability to provide audiovisual and haptic feedback during exercises, indicating its potential for automated monitoring and support in physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SQUID: sensorized shirt with smartphone interface for exercise monitoring and home rehabilitation. Farjadian, AB., Sivak, ML., Mavroidis, C.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The untapped potential of smartphone sensors for stroke rehabilitation and after-care. [2017]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Quantification of Movement in Stroke Patients under Free Living Conditions Using Wearable Sensors: A Systematic Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Wearable technology in stroke rehabilitation: towards improved diagnosis and treatment of upper-limb motor impairment. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Wireless accelerometry is feasible in acute monitoring of upper limb motor recovery after ischemic stroke. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Using Smartphones to Collect Quantitative Data on Lower Limb Functionality in People Who Have Suffered a Stroke. [2019]

6. England pubmed.ncbi.nlm.nih.gov

New-onset atrial fibrillation in a young patient detected by smartwatch. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Mobile Technology for Primary Stroke Prevention: A Proof-of-Concept Pilot Randomized Controlled Trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

'My watch kept on alarming all night about my heart rate': diagnosis of asymptomatic atrial fibrillation with fast ventricular response in a patient with a recent TIA as the result of a smartwatch alarm. [2020]

9. Austria pubmed.ncbi.nlm.nih.gov

[Use of smartphone apps in secondary stroke prevention]. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Perspectives on the prospective development of stroke-specific lower extremity wearable monitoring technology: a qualitative focus group study with physical therapists and individuals with stroke. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Wearable shoe-based device for rehabilitation of stroke patients. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

SQUID: sensorized shirt with smartphone interface for exercise monitoring and home rehabilitation. [2017]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Textile Platform for Assessing Stroke Patient Treatment in Daily Life Conditions. [2020]